Generic Name

Colesevelam Hydrochloride

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Classification

FDA Approved Indications

• Type 2 diabetes mellitus (adjunct to diet and exercise)
• Primary hyperlipidemia (combination or monotherapy)

Mechanism of Action

Bile acid sequestrant that binds bile acids in the intestine, preventing their reabsorption. This leads to increased conversion of cholesterol into bile acids in the liver, thereby reducing LDL cholesterol levels.

Dosage and Administration

Adult: 8 g daily in divided doses or 3.75 g twice daily with meals

Pediatric: Not approved for children; use outside specified age groups only as directed by a healthcare provider

Geriatric: No specific dosage adjustment required, but monitor for constipation and other side effects

Renal Impairment: No adjustment recommended; use caution

Hepatic Impairment: Use with caution; no specific dosage adjustment established

Pharmacokinetics

Absorption: Minimal systemic absorption

Distribution: Not extensively distributed systemically

Metabolism: Not metabolized appreciably, excreted largely unchanged

Excretion: Excreted in feces

Half Life: Not well-defined due to minimal systemic absorption

Contraindications

• Bowel obstruction
• History of hypersensitivity to colesevelam

Precautions

• Monitor for constipation and gastrointestinal side effects
• Use cautiously in patients with triglyceride levels >500 mg/dL
• Can interfere with absorption of fat-soluble vitamins

Adverse Reactions - Common

• Constipation (Common)
• Nausea (Common)
• Disphagia (Less common)

Adverse Reactions - Serious

• Elevated triglycerides (Less common)
• Bowel obstruction (Rare)

Drug-Drug Interactions

• May reduce absorption of oral medications and vitamins; separate dosing by 4 hours
• Thyroid hormone replacement
• Fat-soluble vitamin supplements

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Take medication with meals as directed
• Increase dietary fiber and fluid intake to prevent constipation
• Report persistent gastrointestinal symptoms or signs of vitamin deficiency
• Inform healthcare provider about all medications and supplements

Special Considerations

Black Box Warnings: N/A

Genetic Factors: No known genetic considerations

Lab Test Interference: May interfere with some laboratory tests (e.g., fat-soluble vitamin levels)

Overdose Management

Signs/Symptoms: Potential gastrointestinal discomfort, constipation

Treatment: Supportive care; no specific antidote

Storage and Handling

Storage: Store at room temperature away from moisture and heat

Stability: Stable under recommended storage conditions